NCT00556127

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score

Conditions

• Diffuse Large B-Cell Lymphoma
• POOR PROGNOSIS

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 on day 1
DRUG	Epirubicin	110 mg/m2 on day 3
DRUG	Cyclophosphamide	1200 mg/m2 on day 3
DRUG	Vincristine	1.4 mg/m2 (maximum 2 mg) on day 3
DRUG	Prednisone	40 mg/m2 from day 1 to 5
DRUG	Granulocyte-colony-stimulating factor	(G-CSF 5 μg/Kg/day) from day 5 to day 11
DRUG	Mitoxantrone	8 mg/m2 for 3-day
DRUG	Cytarabine ARA-C	2 g/m2/12 hours for six doses in 3-hour infusion
DRUG	Dexamethasone	4 mg/m2/12 hours before ARA-C administration
DRUG	Carmustine BCNU	300 mg/m2 on day -7
DRUG	Etoposide	100 mg/m2/12 hours
DRUG	Melphalan	140 mg/m2 on day -2
RADIATION	Radiotherapy	Involved Field Radiotherapy (IF-RT)
PROCEDURE	PBSC reinfusion	ASCT

Timeline

• Start date: 2002-06-01
• Completion: 2006-09-01
• First posted: 2007-11-09
• Last updated: 2007-11-09

Locations

14 sites across 1 country: Italy